AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, contents Accu-Chek Advantage repalcement Meter and module, cat. no. 454; Ref. no. 03144798001 contains meter model no. 777.
This recall has been terminated (originally issued August 5, 2006).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- June 22, 2006
- Posted
- August 5, 2006
- Terminated
- April 7, 2008
- Recall Number
- Z-1367-06
- Quantity
- 55,189 meters (for all Recalls Z-1354-1371-06)
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
Distribution
Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
Lot / Code Info
All units.
Root Cause
Other
Action Taken
A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.
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